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FDA 510(k)

ipsogen JAK2 RGQ PCR Kit

K-Number: K172287 · 2018-01-12

ApplicantQiagen, Inc.
Decision Date2018-01-12
Product CodePSU
Advisory CommitteeMG
DecisionSubstantially Equivalent

Device Summary

ipsogen JAK2 RGQ PCR Kit is the device name listed in this FDA 510(k) record. The listed applicant is Qiagen, Inc.. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K172287. The device is classified under product code PSU. It was reviewed by the MG advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ipsogen JAK2 RGQ PCR Kit?

ipsogen JAK2 RGQ PCR Kit is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Qiagen, Inc.. The 510(k) number is K172287.

When did ipsogen JAK2 RGQ PCR Kit receive FDA 510(k) clearance?

ipsogen JAK2 RGQ PCR Kit received FDA 510(k) clearance on 2018-01-12, under 510(k) number K172287.

Who is the listed applicant for ipsogen JAK2 RGQ PCR Kit?

The FDA 510(k) record lists Qiagen, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ipsogen JAK2 RGQ PCR Kit?

The FDA product code for ipsogen JAK2 RGQ PCR Kit is PSU.

Other records listing Qiagen, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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